人源化单抗治疗肿瘤的临床试验分享.ppt

新药 EGF 疫苗 Thanks!! * This was a multicenter, open-labeled, Phase I/II study in patients with histologically verified glioblastoma and anaplastic astrocytoma who had undergone biopsy alone or debulking surgery. All subjects were suitable candidates for radical radiation therapy at the time of inclusion. 29 patients (13 men and 16 women), were entered into the study. Patients received 6 weekly infusions of CIMAher at the 200 mg level. Total MAb cumulative dose was 1200 mg. The antibody was administered by intravenous (IV) infusion, diluted in 250 ml of sodium chloride, over 1 hour. Whole-brain radiation was delivered in doses of 1.8–2 Gy given once daily, five days per week, to a total dose of 50 Gy to 60 Gy. Eight patients showed grade 1 or 2 adverse events consisting of chills, nauseas, fever, asthenia, anorexia, somnolence, cephalea and increase of transaminases or alkaline phosphatase. The most frequent unrelated adverse event consisted in cephalea. Radiation related grade 3/4 alopecia was seen in all patients. None of the patients developed acneiform rash or allergic reactions. A single patient had a positive anti-idiotypic response (IgG subclass) as per the ELISA method. We did not find any association between the immune response against CIMAher and safety or antitumor response. Objective response-rate [complete response (CR) + partial response (PR)] in our series was 37.9% (17.2% CR, 20.7% PR), stable disease (SD) occurred in 41.4% of patients and 20.7% had progressive disease (PD). Median survival time (MST) is 17.47 months for GB, whereas MST is not reached for AA patients. Overall survival rates at 12 and 18 months were 75% and 53.6%. For GB patients, survival rates after combined h-R3 + radiation were 75% at 1 year and 50% at 18 months, while survival rates in the AA group were 75% and 58.3% at 12 and 18 months, respectively. * Therapy consists of six doses given weekly (induction), in cases of stabilization or response, the drug was given weekly (3